About Dash Technologies

Founded in 2010 and headquartered in Dublin, Ohio, USA, Dash Technologies Inc. is a healthcare-focused technology company with a global delivery center in Ahmedabad, India. For more than 15 years, Dash has partnered with healthcare and MedTech organizations to design and engineer digital health solutions spanning Medical IoT, device and system integration, connected applications, artificial intelligence, machine learning, and data analytics. An ISO 9001-certified company, Dash combines robust engineering capabilities with practical execution to advance healthcare’s digital transformation and improve care delivery.

DASH Technology is seeking an experienced professional to lead medical-device documentation and FDA regulatory submissions for Class I, Class II, and Class III devices.

Key Responsibilities

Review the device’s intended use and claims to identify the appropriate FDA classification, regulation number, product code, regulatory pathway, and submission requirements
Develop documentation strategies for Class I, Class II,



and Class III medical devices
Prepare FDA 510(k), De Novo, PMA, and other regulatory submission documentation
Conduct predicate-device searches and prepare Substantial Equivalence comparisons
Prepare Intended Use, Indications for Use, device descriptions, regulatory plans, claims matrices, and eSTAR packages
Develop Design History Files, Medical Device Files, technical files, and product-release documentation
Prepare user needs, system/software requirements, architecture, design specifications, and traceability matrices
Develop IEC 62304 software lifecycle documents, including software plans, requirements, V&V;, anomaly, configuration-management, maintenance, and release records
Prepare ISO 14971 risk documentation, including hazard analyses, FMEAs, risk controls, benefit-risk analyses, and Risk Management Reports
Review cybersecurity, usability, clinical, electrical-safety, biocompatibility, verification, and validati

📌 Manager - Medical Device Quality & Regulatory Documentation (Ahmedabad)
🏢 Dash Technologies
📍 Ahmedabad